US6911007B2 - Method for determining concentration; a dialyser - Google Patents

Method for determining concentration; a dialyser Download PDF

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Publication number
US6911007B2
US6911007B2 US10/025,983 US2598301A US6911007B2 US 6911007 B2 US6911007 B2 US 6911007B2 US 2598301 A US2598301 A US 2598301A US 6911007 B2 US6911007 B2 US 6911007B2
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United States
Prior art keywords
dialysate
citrate
ion
concentration
ion concentration
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime, expires
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US10/025,983
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English (en)
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US20030045827A1 (en
Inventor
Volker Nier
Matthias Kraemer
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Fresenius Medical Care Deutschland GmbH
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Fresenius Medical Care Deutschland GmbH
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Assigned to FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH reassignment FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: NIER, VOLKER, KRAEMER, MATTHIAS
Publication of US20030045827A1 publication Critical patent/US20030045827A1/en
Priority to US11/148,172 priority Critical patent/US7674235B2/en
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/84—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving inorganic compounds or pH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1601—Control or regulation
    • A61M1/1603—Regulation parameters
    • A61M1/1605—Physical characteristics of the dialysate fluid
    • A61M1/1609—Physical characteristics of the dialysate fluid after use, i.e. downstream of dialyser
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1601—Control or regulation
    • A61M1/1617—Control or regulation using measurements made during a temporary variation of a characteristic of the fresh dialysis fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/342—Adding solutions to the blood, e.g. substitution solutions
    • A61M1/3424—Substitution fluid path
    • A61M1/3437—Substitution fluid path downstream of the filter, e.g. post-dilution with filtrate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3607—Regulation parameters
    • A61M1/3609—Physical characteristics of the blood, e.g. haematocrit, urea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3672—Means preventing coagulation
    • A61M1/3675—Deactivation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/18—General characteristics of the apparatus with alarm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/04—Endocrine or metabolic disorders

Definitions

  • Adsorptive therapies for example liver replacement therapy
  • the infusion of the Ca ions and of the Mg ions can also be reduced in order to just compensate the partial withdrawal in the dialyser.
  • This monitoring method is discontinuous since the citrate infusion can only be interrupted for short intervals in order to ensure sufficient anti-coagulation. However, this is sufficient to recognise critical trends in time. In the event of under-dosing or over-dosing, or total failure of the Ca/Mg ion infusion, it namely takes some time until critical concentrations are reached in the body. This time lies at around ten minutes and depends above all on the blood flow.
  • the citrate concentration can be interrupted for a pre-determined time interval and the measured value is determined by integration of the area of the response function defined by the ion concentration in the dialysate as a function of time.
  • the citrate infusion can be interrupted, for example, for a fixed, relatively short time interval, approximately 1 to 2 min. A conclusion can then be made as to the equilibrium concentration by evaluation of the area under a pulse-like response function of the concentration in the dialysate.
  • Such a procedure has the advantage that the dialysate flow does not need to be lowered and thus the dialysis efficiency is not reduced in this time interval.
  • the regulating unit and/or the means for the addition of citrate can be designed such that the concentration of citrate cannot be lowered below a threshold value. It is prevented in this way that the citrate concentration does not fall below a certain value which is required for the effective prevention of coagulation.
  • a substitution solution which contains the Ca ions and Mg ions in an adapted concentration, is infused into the venous side of the extra-corporal circulation.
  • the corresponding substitution solution can naturally also be infused into a separate venous entry of the patient.
  • monitoring systems generally only relate to individual technical components such as the monitoring of a pump with separate or integrated monitoring systems, for example droppers which allow the monitoring of an infusion
  • the monitoring of the ion concentration of the patient in accordance with the invention as the actual physiologically relevant critical parameter includes the whole therapy and thus takes every partial aspect of the method into account.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Anesthesiology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Emergency Medicine (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Cell Biology (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Medicinal Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Cardiology (AREA)
  • Inorganic Chemistry (AREA)
  • External Artificial Organs (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
US10/025,983 2000-12-22 2001-12-26 Method for determining concentration; a dialyser Expired - Lifetime US6911007B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US11/148,172 US7674235B2 (en) 2000-12-22 2005-06-09 Method for determining concentration; a dialyser

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE10064179 2000-12-22
DE10114283.8 2001-03-23
DE10114283A DE10114283C2 (de) 2000-12-22 2001-03-23 Verfahren zur Ermittlung der Ionenkonzentration des Blutes eines Patienten bei der citrat-antikoagulierten Hämodialyse und/oder Hämofiltration; Dialysegerät
DE10064179.2 2001-12-22

Related Child Applications (1)

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US11/148,172 Division US7674235B2 (en) 2000-12-22 2005-06-09 Method for determining concentration; a dialyser

Publications (2)

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US20030045827A1 US20030045827A1 (en) 2003-03-06
US6911007B2 true US6911007B2 (en) 2005-06-28

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US11/148,172 Expired - Fee Related US7674235B2 (en) 2000-12-22 2005-06-09 Method for determining concentration; a dialyser

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Country Status (7)

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US (2) US6911007B2 (de)
EP (2) EP1217379B1 (de)
JP (1) JP4558249B2 (de)
AT (1) ATE463746T1 (de)
DE (2) DE10114283C2 (de)
DK (1) DK1217379T3 (de)
ES (1) ES2343058T3 (de)

Cited By (21)

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US20070066928A1 (en) * 2005-09-22 2007-03-22 Jean-Michel Lannoy Automation and optimization of CRRT treatment using regional citrate anticoagulation
US20080015487A1 (en) * 2006-02-22 2008-01-17 Henry Ford Health System System and Method for Delivery of Regional Citrate Anticoagulation to Extracorporeal Blood Circuits
US20080125693A1 (en) * 2006-08-31 2008-05-29 Gavin David A Peritoneal dialysis systems and related methods
US20080296226A1 (en) * 2007-05-29 2008-12-04 Fresenius Medical Care Holdings, Inc. Solutions, Dialysates, and Related Methods
US20090060890A1 (en) * 2007-08-31 2009-03-05 The Regents Of The University Of Michigan Selective cytopheresis devices and related methods thereof
US20090078622A1 (en) * 2005-06-24 2009-03-26 Fresenius Medical Care Deutschland Gmb Dialyser
US20090221948A1 (en) * 2006-02-22 2009-09-03 Henry Ford Health System System and method for delivery of regional citrate anticoagulation to extracorporeal blood circuits
US7892197B2 (en) 2007-09-19 2011-02-22 Fresenius Medical Care Holdings, Inc. Automatic prime of an extracorporeal blood circuit
US20110168614A1 (en) * 2008-09-09 2011-07-14 Gambro Lundia Ab Device and procedure for extracorporeal blood treatment
WO2014151322A1 (en) 2013-03-14 2014-09-25 Fresenius Medical Care Holdings, Inc. Universal portable machine for online hemodiafiltration using regenerated dialysate
US9433718B2 (en) 2013-03-15 2016-09-06 Fresenius Medical Care Holdings, Inc. Medical fluid system including radio frequency (RF) device within a magnetic assembly, and fluid cartridge body with one of multiple passageways disposed within the RF device, and specially configured cartridge gap accepting a portion of said RF device
US9433720B2 (en) 2013-03-14 2016-09-06 Fresenius Medical Care Holdings, Inc. Universal portable artificial kidney for hemodialysis and peritoneal dialysis
US9566377B2 (en) 2013-03-15 2017-02-14 Fresenius Medical Care Holdings, Inc. Medical fluid sensing and concentration determination in a fluid cartridge with multiple passageways, using a radio frequency device situated within a magnetic field
US9597439B2 (en) 2013-03-15 2017-03-21 Fresenius Medical Care Holdings, Inc. Medical fluid sensing and concentration determination using radio frequency energy and a magnetic field
US9713664B2 (en) 2013-03-15 2017-07-25 Fresenius Medical Care Holdings, Inc. Nuclear magnetic resonance module for a dialysis machine
US9772386B2 (en) 2013-03-15 2017-09-26 Fresenius Medical Care Holdings, Inc. Dialysis system with sample concentration determination device using magnet and radio frequency coil assemblies
US10286135B2 (en) 2014-03-28 2019-05-14 Fresenius Medical Care Holdings, Inc. Measuring conductivity of a medical fluid
US10695482B2 (en) 2011-10-14 2020-06-30 Seastar Medical, Inc. Cartridge and method for increasing myocardial function
US11118162B2 (en) 2010-10-15 2021-09-14 Seastar Medical, Inc. Cytopheresis cartridges and use thereof
US11135345B2 (en) 2017-05-10 2021-10-05 Fresenius Medical Care Holdings, Inc. On demand dialysate mixing using concentrates
US11504458B2 (en) 2018-10-17 2022-11-22 Fresenius Medical Care Holdings, Inc. Ultrasonic authentication for dialysis

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US8105258B2 (en) 1999-04-26 2012-01-31 Baxter International Inc. Citrate anticoagulation system for extracorporeal blood treatments
US7351218B2 (en) * 2002-12-20 2008-04-01 Gambro Lundia Ab Device and process for extracorporeal treatment by citrate anticoagulant
US20060217771A1 (en) * 2005-02-07 2006-09-28 Medtronic, Inc. Potassium monitoring
US7884132B2 (en) * 2005-11-14 2011-02-08 The Uab Research Foundation Process for metabolic control and high solute clearance and solutions for use therein
DE102007004115B4 (de) 2007-01-26 2010-05-06 Fresenius Medical Care Deutschland Gmbh Dialysemaschine und Verfahren zur Feststellung der Verkalkung einer Dialysemaschine
AT505690B1 (de) * 2007-08-31 2012-09-15 Zentrum Fuer Biomedizinische Technologie Der Donau Uni Krems Verfahren zum erfassen der ionenkonzentration bei citrat-antikoagulierter extrakorporaler blutreinigung
CN102378631B (zh) 2009-03-31 2015-08-19 甘布罗伦迪亚股份公司 多部分式流体系统和用于在体外血液回路中局部柠檬酸盐抗凝的系统
WO2010148194A1 (en) * 2009-06-17 2010-12-23 Fresenius Medical Care Holdings, Inc. Methods of regional citrate anticoagulation dialysis
US9399091B2 (en) 2009-09-30 2016-07-26 Medtronic, Inc. System and method to regulate ultrafiltration
DE102011010406A1 (de) * 2011-02-04 2012-08-09 Fresenius Medical Care Deutschland Gmbh Verfahren zum Steuern einer Blutbehandlungvorrichtung, Steuereinrichtung, Zugabeeinrichtung und Blutbehandlungsvorrichtung
US9848778B2 (en) 2011-04-29 2017-12-26 Medtronic, Inc. Method and device to monitor patients with kidney disease
US8951219B2 (en) 2011-04-29 2015-02-10 Medtronic, Inc. Fluid volume monitoring for patients with renal disease
US9456755B2 (en) 2011-04-29 2016-10-04 Medtronic, Inc. Method and device to monitor patients with kidney disease
ITBO20110302A1 (it) * 2011-05-25 2012-11-26 Bellco Srl Gruppo di infusione di una macchina da dialisi
EP2653178A1 (de) 2012-04-16 2013-10-23 Zentrum für biomedizinische Technologie der Donau- Universität Krems Sicherheitseinrichtung für eine extrakorporale Blutbehandlung
US10905816B2 (en) 2012-12-10 2021-02-02 Medtronic, Inc. Sodium management system for hemodialysis
US9707328B2 (en) 2013-01-09 2017-07-18 Medtronic, Inc. Sorbent cartridge to measure solute concentrations
US9526822B2 (en) 2013-02-01 2016-12-27 Medtronic, Inc. Sodium and buffer source cartridges for use in a modular controlled compliant flow path
US9827361B2 (en) 2013-02-02 2017-11-28 Medtronic, Inc. pH buffer measurement system for hemodialysis systems
DE102013104501A1 (de) 2013-05-02 2014-11-06 B. Braun Avitum Ag Vorrichtung zur extrakorporalen Blutbehandlung
EP3000088A4 (de) 2013-05-23 2018-06-27 Iphenotype LLC Verfahren und system zur bewahrung oder verbesserung des wohlbefindens
US10076283B2 (en) 2013-11-04 2018-09-18 Medtronic, Inc. Method and device to manage fluid volumes in the body
EP2959928A1 (de) * 2014-06-26 2015-12-30 Infomed SA Vorrichtung zur Blutreinigung durch extrakorporale Zirkulation
DE102014111665A1 (de) * 2014-08-14 2016-02-18 B. Braun Avitum Ag Verfahren zum Einstellen eines Blutflusses in einer Dialysevorrichtung und Dialysevorrichtung
EP3015124B1 (de) * 2014-10-31 2017-08-16 B. Braun Avitum AG System zur flexiblen Zitratantikoagulation während einer extrakorporalen Blutbehandlung mit Vorwärtsregelung
US10994064B2 (en) 2016-08-10 2021-05-04 Medtronic, Inc. Peritoneal dialysate flow path sensing
US10874790B2 (en) 2016-08-10 2020-12-29 Medtronic, Inc. Peritoneal dialysis intracycle osmotic agent adjustment
DE102016009442A1 (de) * 2016-08-03 2018-02-08 Fresenius Medical Care Deutschland Gmbh Verfahren zur Überwachung des Bicarbonat-Gehalts und des Natrium-Gehalts einer Dialyselösung
US11013843B2 (en) 2016-09-09 2021-05-25 Medtronic, Inc. Peritoneal dialysis fluid testing system
CN110382018B (zh) * 2017-03-02 2022-04-29 旭化成医疗株式会社 血液净化装置
EP3590563B1 (de) * 2017-03-02 2020-09-23 Asahi Kasei Medical Co., Ltd. Blutreinigungsvorrichtung
US11806457B2 (en) 2018-11-16 2023-11-07 Mozarc Medical Us Llc Peritoneal dialysis adequacy meaurements
US11806456B2 (en) 2018-12-10 2023-11-07 Mozarc Medical Us Llc Precision peritoneal dialysis therapy based on dialysis adequacy measurements
BR112021011191A2 (pt) * 2018-12-11 2021-08-24 Gambro Lundia Ab Monitoramento de desempenho da anticoagulação com citrato regional
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US11965763B2 (en) 2021-11-12 2024-04-23 Mozarc Medical Us Llc Determining fluid flow across rotary pump
US11944733B2 (en) 2021-11-18 2024-04-02 Mozarc Medical Us Llc Sodium and bicarbonate control
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EP1217379A2 (de) 2002-06-26
US20030045827A1 (en) 2003-03-06
ES2343058T3 (es) 2010-07-22
EP2194384A3 (de) 2010-10-27
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US7674235B2 (en) 2010-03-09
DE10114283A1 (de) 2002-07-11
JP2002248165A (ja) 2002-09-03
JP4558249B2 (ja) 2010-10-06
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US20050236330A1 (en) 2005-10-27
DE50115425D1 (de) 2010-05-20

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